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Exercise and Cognition Among Stroke Survivors (EXERCISES)

L

Leeds Beckett University

Status

Completed

Conditions

Aerobic Exercise
Resistance Exercise

Treatments

Behavioral: Resistance exercise
Behavioral: aerobic exercise

Study type

Interventional

Funder types

Other

Identifiers

NCT06848998
17/EE/0409

Details and patient eligibility

About

This study aimed to: (1) identify a suitable cardiopulmonary exercise testing protocol for people with moderate to severe movement impairments after stroke by investigating the safety and feasibility of delivering two methods of CPET modes: treadmill with body-weight support (TBWS) and cycle ergometry (CE); and (2) explore the safety and feasibility of a delivering a 6-week exercise-based intervention or people with moderate to severe movement impairments after stroke, with a view to improve cognitive health.

Enrollment

24 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Have provided informed consent,
  • Are aged >18 years,
  • Are more than 6 months post-stroke,
  • Score 2-3 on the Functional Ambulation Category
  • Can follow 1-stage commands i.e. sufficient communication/orientation for interventions in the trial.

Exclusion criteria

  • Attending any other community exercise class/gym/walking group/rehabilitation class,
  • A previous diagnosis of dementia or any other significant cognitive decline,
  • Any musculoskeletal or neurophysiological disorder preventing participation in exercise,
  • Have uncontrolled hypertension, atrial fibrillation, heart failure or diabetes.
  • Weigh over 250lbs/113kg (due to weight restrictions on body-weight support harness on treadmill),
  • Meeting any absolute or relative contraindication to exercise from American College of Sports Medicine (ACSM)

Contraindications to Exercise 2014, see below:

Absolute contraindications to exercise:

  • A recent significant change in the resting ECG suggesting significant ischaemia, recent myocardial infarction (within 2 days) or other acute cardiac event
  • Unstable angina
  • Uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise
  • Symptomatic severe aortic stenosis
  • Uncontrolled symptomatic heart failure
  • Actuate pulmonary embolus or pulmonary infarction
  • Acute myocarditis or pericarditis
  • Suspected or know dissecting aneurysm
  • Acute systematic infection, accompanied by fever, body aches or swollen lymph glands

Relative contraindications to exercise:

  • Left main coronary stenosis
  • Moderate stenotic valvular heart disease
  • Electrolyte abnormalities e.g. hypokalaemia, hypo-magnesia
  • Severe arterial hypertensions i.e. systolic BP of >200mmHg and/or diastolic BP of >110mmHg at rest
  • Tachydysrthythmia or bradydsrhythmia
  • Hypertrophic cardiomyopathy and other forms of outflow tract obstruction
  • Neuromuscular, musculoskeletal or rheumatoid disorders that are exacerbated by exercise
  • High-degree atrioventricular block
  • Ventricular aneurysm
  • Uncontrolled metabolic disease e.g. diabetes, thyrotoxosis or myxedemia Chronic infectious diseases e.g. mononucleosis, hepatitis, AIDs
  • Mental or physical impairment leading to inability to exercise adequately

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

24 participants in 2 patient groups

Aerobic exercise
Experimental group
Treatment:
Behavioral: aerobic exercise
Resistance exercise
Active Comparator group
Treatment:
Behavioral: Resistance exercise

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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